The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1507-2025·Announced 2025-04-23

BD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks

Bard Access Systems is recalling BD 4 Fr Single-Lumen PowerPICC Catheters worldwide because tubing material may exceed specifications, causing leaks and potentially serious complications including infection and air embolism.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a medical device. The rubric states that FDA Class I recalls are "never below 4" in severity score. The hazard involves risk of serious complications including air embolism and infection, which are life-threatening or serious injury risks, meeting the Severe (score 4) threshold.

Plain-English summary

Bard Access Systems, Inc. is recalling BD 4 Fr Single-Lumen PowerPICC Catheters used for short- or long-term access to the central venous system. The tubing in affected units exceeded melt flow index specification, which could lead to increased material fatigue and leaks.

Leaks in these catheters could result in infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection, and interruption to therapy.

The affected catheters have been distributed worldwide, including throughout the United States and internationally. A total of 718,461 units are affected across numerous reference numbers and lot codes with expiration dates ranging from May 2025 through November 2027.

Patients and healthcare providers should contact Bard Access Systems, Inc. if they have questions about affected catheters. For full lot and reference information, consult the FDA website or the manufacturer.

The recalled product

Product
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D…
Manufacturer
Bard Access Systems, Inc.
Category
Medical Device — Central Venous Catheter
Hazard
Affected units
718,461

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025)
  • REGZ1439(11/30/2025)
  • REHP0860(11/30/2025)
  • REHQ3097(6/30/2026)
  • REHR0022(6/30/2026)
  • REHT1151(7/31/2026)
  • REHU1525(11/30/2026)
  • REHU2455(6/30/2026)
  • REHU2614(11/30/2026)
  • REHV2765 (7/31/2026)
  • REJN3472(2/28/2027)
  • REJP4216(5/31/2027)
  • REJQ2272(7/31/2027)
  • REJR1411(8/31/2027)
  • REJR2565(4/30/2027)
  • REJR2614(8/31/2027)
  • REJT0755(9/30/2027)
  • CK000540/00801741105142/REGZ1425(10/31/2025)
  • REHP0808(11/30/2025)
  • REHU1513(1/31/2026)

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Related recalls

Same manufacturer · Bard Access Systems, Inc.

See all →

Similar recalls